Neuromodulation and Yoga for mTBI and Chronic Pain

Chronic Pain Clinical Trial

Official title: Feasibility of a Combined Neuromodulation and Yoga Intervention for Veterans With Mild Traumatic Brain Injury and Chronic Pain

Status Completed

Clinical Trial Summary

The objectives of this VA SPiRE application are to develop a combined neuromodulation and yoga (iTBS+yoga) intervention for Veterans with mild traumatic brain injury (mTBI) and chronic pain, assess the intervention's feasibility and acceptability, and to gather preliminary clinical outcome data on quality of life, function and pain that will guide future studies. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. Neuromodulation is now offered at 30 VA hospitals and yoga is among the complementary and integrative health programs being rolled out as a part of VAs Whole Health implementation efforts. Thus, should iTBS+yoga ultimately prove to be efficacious, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain.

Clinical Trial Description

Over 340,000 people have incurred a mild traumatic brain injury (mTBI) as a result of the military conflicts in Iraq and Afghanistan. mTBI leads to a host of poor rehabilitation outcomes including impairments in cognition, physical health, and psychological health. These impairments among people with TBI lead to poor quality of life (QOL). Worsening this clinical picture, the prevalence of chronic pain is estimated to be 51.5% among civilians with TBI and 43.1-70% among Veterans with TBI. Opioids are used for treating chronic pain including among people with TBI. Thus, given the ongoing opioid epidemic in the United States, it is very timely to develop alter-native, non-pharmacologic treatments for chronic pain among Veterans with mTBI. Yoga is a promising activity-based intervention for TBI and chronic pain. Yoga is an activity generally comprised of breathing exercises, gentle stretching, and meditation. Neuromodulation through transcranial magnetic stimulation (TMS) is a prom-ising non-invasive, non-pharmacological treatment for TBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory TMS. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS shows promise to prime the brain for combined interventions and may magnify the impacts that these interventions would have when used alone, in order to boost outcomes. The purpose of this SPiRE project is to develop a novel, combined neuromodulation and yoga neurorehabilitation intervention for Veterans with mTBI and chronic pain, and to examine the intervention's feasibility and acceptability. Using an existing, evidence-based, yoga program created specifically for people with TBI (LoveYourBrain Yoga), the investigators will first develop a neurorehabilitation intervention that combines iTBS with yoga (iTBS+yoga), and then collect pilot data about its feasibility and acceptability. Aim 1 will develop a novel, combined iTBS+yoga neurorehabilitation intervention for Veterans with mTBI and chronic pain. Aim 2 will examine the feasibility and acceptability of the iTBS+yoga intervention for Veterans with mTBI and chronic pain. Aim 3 will gather preliminary data to provide the foundation for sample size and power considerations for a future clinical trial to examine the effectiveness of iTBS+yoga on Veterans' quality of life, function and pain out-comes. The combined intervention will be provided in small group settings once a week for 6 weeks. iTBS will be administered immediately prior to the LoveYourBrain Yoga session. Emphasizing National Institute of Neuro-logical Disorders and Stroke (NINDS) Traumatic Brain Injury Common Data Elements (TBI CDEs), the investigators will collect preliminary outcome data related to quality of life, function and pain to inform a future Merit application, should the intervention prove feasible. This SPiRE project will directly benefit Veterans and VA Services by developing a new, non-pharmacological neurorehabilitation treatment for Veterans with mTBI and chronic pain in need of non-opioid treatment options. TMS is now offered at 30 VA hospitals nationwide for treatment-resistant depression, and yoga is among the complementary and integrative health programs being rolled out as a part of VAs nation-wide Whole Health implementation efforts, with classes offered through VA service lines such as recreational therapy. Therefore, should iTBS+yoga ultimately prove to be efficacious and effective, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-pharmacological treatment for Veterans with mTBI and chronic pain is of great need given the high prevalence of chronic pain, increased risk of opioid therapy, and increased risk of developing opioid use disorders. ;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Chronic Pain
• Mild Traumatic Brain Injury

• NCT number: NCT04517604
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Completion date: August 31, 2023